Arjo Malibu - Standards and Certificates; Compliance Standards

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List of Standards and Certificates
STANDARDS/CERTIFICATES DESCRIPTION
EN ISO 10535:2006 Hoist for transfer of disabled persons
EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1
EN 1717:2000 Protection against pollution of potable water in water installations and
general requirements of devices to prevent pollution by backflow
UL 94 Revision 9 Tests for Flammability of Plastic Materials for Parts in Devices and
Appliances
NHS D08 TMV3 The TMV3 Scheme - thermostatic Mixing Valve testing for the National
Health Service
IEC 60601-1-6:2010 +A1:2013 Medical electrical equipment - Part 1-6: - Collateral standard: Usability
IEC 60601-1:2005+A1 2012 Medical electrical equipment - Part 1: General requirements for safety
EN 60601-1-2:2015 Electromagnetic compliance
IEC 60601-1-11:2015 General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment
and medical electrical systems used in the home healthcare
environment
UL/CB
ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012, CSA CAN/CSA-C22.2 NO. 60601-1:14
IEC 60601-1:2005 + A1:2012
IEC60601-1-11:2015
WRAS (Water Fittings) Regulations 1999 (the Water Byelaws 2000 in
Scotland)